CN105362963A - Pharmaceutical preparation for treating hypomenorrhea of congealing cold and blood stasis - Google Patents
Pharmaceutical preparation for treating hypomenorrhea of congealing cold and blood stasis Download PDFInfo
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- CN105362963A CN105362963A CN201510968325.3A CN201510968325A CN105362963A CN 105362963 A CN105362963 A CN 105362963A CN 201510968325 A CN201510968325 A CN 201510968325A CN 105362963 A CN105362963 A CN 105362963A
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- hypomenorrhea
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Abstract
The invention belongs to the field of medicines, and discloses a pharmaceutical preparation for treating hypomenorrhea of congealing cold and blood stasis. The pharmaceutical preparation is prepared by taking cyperus iria Linn., triplostegia glandulifera Wall. ex DC., semen cuscutae, fructus evodiae, desmodium triflorum (L.) DC., astragalus complanatus, carex siderosticta hance, litsea coreana Levl.var, curcuma, embelia parviflora, leonurus, arillus longan and rhododendron as medicinal raw materials and carefully mixing the raw materials in parts by weight. The pharmaceutical preparation has the efficacies of warming kidney and spleen, warming meridians to dissipate cold, activating blood circulation to dissipate blood stasis, and nourishing blood for regulating menstruation. Clinical experiments show that the pharmaceutical preparation can obviously improve the clinical cure rate and the efficiency rate of hypomenorrhea compared with control groups, can obviously improve clinical symptoms of a patient, has a better long-term efficacy, enables the relapse possibility of the clinical symptoms of the patient to be low, is less in adverse reaction, and is safe and effective, so that a new method for treating hypomenorrhea through a traditional Chinese medicine is provided.
Description
Technical field
The invention belongs to the field of Chinese medicines, relate to the medicine for the treatment of menoxenia, particularly relate to a kind of pharmaceutical preparation for the treatment of cold blood stasis type Hypomenorrhea.
Background technology
Menstruation is the outward manifestation of female reproduction physiological activity, is also the most important physiological foundation of women.Menoxenia is gynecological clinic commonly encountered diseases, comprises preceeded menorrhea, delayed menstrual cycle, menstruation successively irregular, menorrhagia, hypomenorrhea, menostaxis.Menstrual cycle is normal, and through measuring obvious minimizing, even drop is namely clean; Or menstrual period shorten less than two days, also lack person through amount, be all called " hypomenorrhea ", belong to menopathy.If treated not in time, can amenorrhea be developed into, even infertile, also bring serious mental pressure to patient simultaneously.
Hypomenorrhea ancient medicine has discussion more.Zhu Zhenheng " red small stream Xin Fa ﹒ controls through water card " claims assertive evidence " through water pettiness ", " a small amount of menses and menstruating unsmoothly " also adds taste with SIWU TANG and control it.Wang Kentang " Zheng controls Zhun Sheng ﹒ gynecological " follows ZHU Dan-xi viewpoint and proposes " a small amount of menses and menstruating unsmoothly, for void is puckery, then need mend it, puckery moistens it ".Modern Chinese medicine scholar thinks that the hypomenorrhea cause of disease has void to have reality more, and empty person can because of ferritic blood deficiency, or the sick blood trouble of serious disease prolonged illness; Deficiency of nutrient QI and blood, or diet, overstrain, worry impairing spleen, insufficiency of the spleenization source is not enough, can make menoxenia due to insufficiency of CHONG meridian; Or because of natural endowment element weak, or juvenile kidney qi is not filled, or fecund (comprising spontaneous abortion and artificial abortion) impairment of the kidney due to indulgence in sexual activities, so that deficiency of kidney-QI, and essence and blood does not fill, menoxenia due to insufficiency of CHONG meridian; Reality person is as experienced cold-evil, and cold objective uterus, blood is cold coagulation, or qi depression to blood stasis, retardance vessels of the uterus, or plain excessive phlegm wets, or dysfunction of the spleen in transportation, and accumulatively wet raise phlegm, stagnation of phlegm, through then, all can not pass unimpeded in hyperamization.
Doctor trained in Western medicine thinks that menstruation refers to that cause with the cyclically-varying of the Estrogen and progestin of the ovulation of ovarian cycle property and secretion thereof endometrial comes off and hemorrhage.Female normal menstruation depends on the normal neuronal endocrine function of hypothalamic-pituitary-ovarian axis and mutually coordinates and normergic endometrium.Doctor trained in Western medicine does not have the name of disease of hypomenorrhea, the pathogenic factor of hypomenorrhea mainly contains the uterine factors such as uterine hypoplasia, endometrial tuberculosis, endometritis, the Ovarian factors such as premature ovarian failure or pure gonadal hypoplasia, hypothalamus promotes that gonad releasing hormone or pituitary gonadotropic hormone secretion are lowered or imbalance, artificial abortion dilatation and curettage of uterine is crossed deeply or the endometrial basal layer of uterine cavity electrocautery equivalent damage causes intrauterine adhesion etc., long-term taking some drugs (as oral contraceptive), other series of disease such as hyperthyroidism.
Doctor trained in Western medicine does not have concrete therapeutic scheme, and tcm clinical practice treatment hypomenorrhea is in the epoch of letting a hundred schools contend, and numerous doctor has different treatment thoughts according to respective clinical experience, and clinical confirmation has good clinical efficacy.The traditional Chinese medical science has stable curative effect, advantage that toxic and side effects is little in treatment endocrinopathy and metabolic disease.
Summary of the invention
Opinion in Zhang Jingyue " scape Yue Quan book ﹒ married woman returns " " color is how not fresh for all YANG QI deficiency, hematofrigid delayed menstruation person, or not smooth and lack, " thinks that cold in blood is not transported and causes hypomenorrhea.Inventor combines theory and the clinical experience of oneself of the sage of the past at all times, by modern physiological pathology and pathogen and pathology of tcm, dialectically to combine with differential diagnosis of diseases, accordingly, provide a kind of pharmaceutical preparation for the treatment of cold blood stasis type Hypomenorrhea, it has warming the spleen warming the kidney, dispelling cold by warming the meridian, blood circulation promoting and blood stasis dispelling, the effect of nourishing blood for regulating menstruation is a kind of ideal medicament for the treatment of cold blood stagnation Hypomenorrhea.
The technical solution used in the present invention is:
Treat a pharmaceutical preparation for cold blood stasis type Hypomenorrhea, it selects gold grass by Herba Cyperi Iriae, Radix Triplostegiae Grandiflorae, Semen Cuscutae, Fructus Evodiae, three, Semen Astragali Complanati, Radix caricis siderostictae, Litsea coreana, Rhizoma Curcumae Longae, Radix seu Caulis Embeliae Parviflorae, Herba Leonuri, Arillus Longan, Folium Rhododendri Simsii be that medicinal raw material is made.
Inventor on prescription is selected multiplex warming the meridian, cold expelling, circulation of qi promoting, dissipating blood stasis, enrich blood, supporing yang product, the indivedual single medicinal materials in prescription have the effect for the treatment of menoxenia, but are all not enough to have good clinical therapeutic efficacy.In order to strengthen the synergism of effective active composition in medicine, the present inventor, on the basis of secret prescription handed down in the family from generation to generation, through the test of long-term, a large amount of screening prescriptions, optimizes following technical scheme further:
Treat a pharmaceutical preparation for cold blood stasis type Hypomenorrhea, it is made up of the medicinal raw material of following weight portion: Herba Cyperi Iriae 20-30 part, Radix Triplostegiae Grandiflorae 20-40 part, Semen Cuscutae 15-25 part, Fructus Evodiae 5-9 part, three select the careless 13-18 part of gold, Semen Astragali Complanati 15-20 part, Radix caricis siderostictae 10-15 part, Litsea coreana 10-15 part, Rhizoma Curcumae Longae 4-7 part, Radix seu Caulis Embeliae Parviflorae 18-26 part, Herba Leonuri 8-13 part, Arillus Longan 15-20 part, Folium Rhododendri Simsii 5-15 part.
Further preferably, treat a pharmaceutical preparation for cold blood stasis type Hypomenorrhea, it is made up of the medicinal raw material of following weight portion: Herba Cyperi Iriae 24-28 part, Radix Triplostegiae Grandiflorae 28-32 part, Semen Cuscutae 18-23 part, Fructus Evodiae 5-9 part, three select the careless 13-18 part of gold, Semen Astragali Complanati 15-20 part, Radix caricis siderostictae 10-15 part, Litsea coreana 10-15 part, Rhizoma Curcumae Longae 4-7 part, Radix seu Caulis Embeliae Parviflorae 20-25 part, Herba Leonuri 8-13 part, Arillus Longan 15-20 part, Folium Rhododendri Simsii 10-15 part.
Further preferably, treat a pharmaceutical preparation for cold blood stasis type Hypomenorrhea, it is made up of the medicinal raw material of following weight portion: Herba Cyperi Iriae 25 parts, Radix Triplostegiae Grandiflorae 30 parts, Semen Cuscutae 20 parts, Fructus Evodiae 8 parts, three select gold grass 15 parts, Semen Astragali Complanati 15 parts, Radix caricis siderostictae 12 parts, Litsea coreana 10 parts, 6 parts, Rhizoma Curcumae Longae, Radix seu Caulis Embeliae Parviflorae 23 parts, Herba Leonuri 12 parts, Arillus Longan 18 parts, Folium Rhododendri Simsii 12 parts.
Fang Zhong: the pungent tepor of Herba Cyperi Iriae, kind functions dispelling wind and clearing away cold, removing dampness, promoting blood flow to regulate menstruation; Radix Triplostegiae Grandiflorae tonifying speen and tonifying kidney, nourishing blood and promoting blood circulation regulating menstruation; The sweet temperature of Semen Cuscutae, kind reinforcing the kidney and supporting YANG activating QI, warming the spleen helps the strong fortune of stomach, and void can be mended, in fact can be in order to, cold can temperature, three medicine 5 use, warming and recuperating the spleen and kidney, strengthening vital QI to eliminate pathogenic factors, nourshing blood and promoting blood circulation regulating menstruation, for controlling the monarch drug of the Hypomenorrhea that cold blood stasis causes.Pungent warm taste of Fructus Evodiae and cold expelling is evil, warming middle-JIAO to promote flow of QI, make the heresy that wind and cold is wet, go out from space between skin and muscles; 3 careless promoting the circulation of QI to relieve pain of gold, dispelling cold by warming the meridian, two medicine 5 principal drug assistance dispelling cold by warming the meridian, warming middle-JIAO to relieve pain; The sweet temperature of Semen Astragali Complanati, temperature compensation Liver and kidney, principal drug assistance promotes the production of body fluid activating QI, and Radix caricis siderostictae Gan Xinwen, benefiting QI and nourishing blood, promoting blood flow to regulate menstruation, tool is ministerial drug.Litsea coreana warming middle-JIAO to relieve pain, row aquation of regulating the flow of vital energy is stagnant; The arduous temperature of Rhizoma Curcumae Longae, benefaction gas removing blood stasis, inducing menstruation to relieve menalgia; The pained temperature of Radix seu Caulis Embeliae Parviflorae, enriches blood and invigorates blood circulation, dissipating blood stasis regulating menstruation, strong waist knee joint; Herba Leonuri toil is slightly cold, and property benefaction is walked, and can promoting the circulation of blood nourish blood, and promoting the circulation of blood and do not hinder fresh blood, nourishes blood and not stagnant blood stasis, can the property of Zuo Xinwen blood circulation promoting medicine; Arillus Longan invigorating the heart and spleen, nourishing blood to tranquillize the mind; Folium Rhododendri Simsii regulating menstruation by adjusting the flow of blood is adjuvant.Full side closes 5, and having warming the spleen warming the kidney, dispelling cold by warming the meridian, blood circulation promoting and blood stasis dispelling, the effect of nourishing blood for regulating menstruation, is a kind of ideal medicament for the treatment of cold blood stagnation Hypomenorrhea.
The pharmaceutical research present situation of the present invention's each medical material used is as described below.
Herba Cyperi Iriae: [nature and flavor] acrid in the mouth; Slightly warm in nature.[return through] Liver Channel.[function cures mainly] expelling wind and removing dampness; Promoting blood flow to regulate menstruation.Main air wets bones and muscles pain; Paralysis; Menoxenia; Amenorrhea; Educate through; Traumatic injury.
Semen Cuscutae: [nature and flavor] are sweet, temperature.[return through] returns liver,kidney,spleen warp.[function cures mainly] nourishing the liver and kidney, controlling nocturnal emission with astringent drugs reducing urination, antiabortive, improving eyesight, antidiarrheal.For impotence and seminal emission, dripping urination, enuresis frequent micturition, soreness of the waist and knees, blurred vision tinnitus, vaginal bleeding due to deficiency of the kidney during pregnancy, frequent fetal movement, spleen is suffered from a deficiency of the kidney and is rushed down; Externally treating leucoderma.[usage and dosage] 6 ~ 12g; Suitable amount used externally.
Radix Triplostegiae Grandiflorae: [nature and flavor] sweet, micro-hardship is flat.[function cures mainly] tonifying speen and tonifying kidney, promoting blood flow to regulate menstruation, only metrorrhagia, removing toxic substances.For lumbago due to renal deficiency, anemia, cough, seminal emission, sexual impotence, rheumatic arthritis, menoxenia, vicarious menstruation, metrorrhagia, leukorrhagia, infertility.External is stopped blooding." Yunnan Chinese herbal medicine ": regulating menstruation and activating blood, kidney tonifying.Control amenorrhea, menoxenia, lumbago due to renal deficiency, seminal emission, sexual impotence, infertility.
Fructus Evodiae: [nature and flavor] are pungent, bitter, heat; Slightly poisonous.[return through] returns liver, spleen, stomach, kidney channel.[function cures mainly] dispersing cold for relieving pain, stopping nausea and vomiting by lowering the adverse flow of QI, supporing yang antidiarrheal.For headache due to JUE YIN disorder, colic of cold type is suffered from abdominal pain, the disturbance of lower legs due to pathogenic cold and dampness, abdominal pain during menstruation, abdominal distention, vomiting acid regurgitation, Diarrhoea, external treatment aphtha; Hypertension." book on Chinese herbal medicine converge with speech ": Fructus Evodiae, dissipating depression of QIization is stagnant, by cold sending down the abnormal ascending QI medicine also.Fang Longtan says, the disease of all trouble lower abdomeies, few abdomen YIN-cold, or vomiting is felt sick and acid regurgitation acid regurgitation, or obstruction and rejection expectorant is poly-and every food trapping, or taste stop cold and diarrhea of having loose bowels, or the pent-up of liver spleen and the inverse food of distension, or hernia abdominal mass string gas and attack and draw lower abdomen, or cardiac beriberi and vomit the sound of vomiting bitter, be the card of all liver spleen kidney channels also, Fructus Evodiae all can control it.
3 gold grass: [nature and flavor] are bitter, micro-pungent, temperature.[function cures mainly] promoting the circulation of QI to relieve pain, dispelling cold by warming the meridian, removing toxic substances.For heatstroke stomachache, colicky, menoxenia, dysmenorrhea, puerperal arthralgia, rabies.
Semen Astragali Complanati: [nature and flavor] are sweet, temperature.[return through] returns liver, kidney channel.[function cures mainly] temperature compensation Liver and kidney, controlling nocturnal emission with astringent drugs, reducing urination, improving eyesight.For lumbago due to renal deficiency, seminal emission premature ejaculation, nebulousurine leukorrhagia, dribbling urination, dizzy blurred vision.
Radix caricis siderostictae: [nature and flavor] sweet in the mouth; Pungent; Warm in nature.[return through] lung; Liver; Kidney channel.[function cures mainly] benefiting QI and nourishing blood; Promoting blood flow to regulate menstruation.Main deficient qi and blood; Lassitude; Palpitation and insomnia; Menoxenia; Amenorrhea.
Litsea coreana: [nature and flavor] are pungent; Bitter; Temperature.[return through] stomach; Spleen channel.[function cures mainly] warming middle-JIAO to relieve pain; To regulate the flow of vital energy row water.Main epigastric distending pain; Edema.
Rhizoma Curcumae Longae: [nature and flavor] are pungent, bitter, temperature.[return through] returns spleen, Liver Channel.The circulation of qi promoting of [function cures mainly] removing blood stasis, inducing menstruation to relieve menalgia.Twinge for the breast side of body, amenorrhea ， WEIJIA, rheumatism shoulder arm pain, tumbling and swelling." Japan hanako materia medica ": " control lump in the abdomen clot, carbuncle, logical menstruation, controls to fall and flutter blood stasis, detumescence poison; Only storm wind pain cold air, lower food.”
Radix seu Caulis Embeliae Parviflorae: [nature and flavor] are bitter; Puckery; Warm in nature.[return through] liver; Kidney channel.[function cures mainly] enriches blood; Invigorate blood circulation; Strong waist knee joint.The all cards of main blood deficiency; Menoxenia; Amenorrhea; Puerperal asthenia; Waist and leg ache; Injury and bone fracture.
Herba Leonuri: [nature and flavor] are bitter, pungent, are slightly cold.[return through] returns liver, pericardium channel.[function cures mainly] promoting blood flow to regulate menstruation, inducing diuresis to remove edema.For menoxenia, dysmenorrhea, amenorrhea, lochiorrhea, edema oliguria; Acute nephritis edema.
Arillus Longan: [nature and flavor] are sweet, temperature.[return through] GUIXIN, spleen channel.[function cures mainly] invigorating the heart and spleen, nourishing blood to tranquillize the mind.For insufficiency of vital energy and blood, severe palpitation, forgetful insomnia, blood deficiency and yellow complexion.
Folium Rhododendri Simsii: [nature and flavor] are sweet, acid, property is put down.[return through] liver; Spleen; Kidney channel.[function cures mainly] and blood; Regulating menstruation; Cough-relieving; Wind-damp dispelling; Separate sore.Main haematemesis; Epistaxis; Metrorrhagia; Menoxenia; Cough; Rheumatic arthralgia; Carbuncle furuncle poison.
In order to express pharmaceutical preparation of the present invention better, pharmaceutical preparation of the present invention can by Herba Cyperi Iriae, Radix Triplostegiae Grandiflorae, Semen Cuscutae, Fructus Evodiae, three select gold grass, Semen Astragali Complanati, Radix caricis siderostictae, Litsea coreana, Rhizoma Curcumae Longae, Radix seu Caulis Embeliae Parviflorae, Herba Leonuri, Arillus Longan, Folium Rhododendri Simsii or its water or its extractive with organic solvent is active component, this composition is independent or mix with medicine acceptable carrier, makes according to galenic pharmacy routine techniques.
Described pharmaceutically acceptable carrier, as mannitol, sorbitol, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin C, EDETATE SODIUM, Ethylenediaminetetraacetic Acid Calcium Salt, the alkali-metal carbonate of monovalence, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulphuric acid, phosphoric acid, aminoacid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and its derivates, alginate, gelatin, polyvinylpyrrolidone, glycerol, POLYSORBATE 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc.
Pharmaceutical preparation of the present invention is preferably made for peroral dosage form, as: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, honey pill agent, powder, sublimed preparation, solution or plaster etc.
The peroral dosage form of pharmaceutical preparation further preferably of the present invention is tablet, capsule or granule, most preferably is capsule.
Present invention also offers the preparation method of this kind of pharmaceutical preparation of the present invention, the present inventor finds under study for action, by optimized fabrication method, can when remaining valid medicine, remove impurity or the part without drug effect, reduce impurity to the interference of therapeutic effect, make this pharmaceutical preparation more effective, and reduce the consumption of medicine thus.
A kind of preparation method for the treatment of the pharmaceutical preparation of caused by hepatic stagnation qi stagnation hypomenorrhea provided by the invention, mainly comprises the following steps:
(1) Herba Cyperi Iriae, 3 gold grass, Litsea coreana, Rhizoma Curcumae Longae, Herba Leonuri, Folium Rhododendri Simsiis are pulverized, the ethanol water of 50% of 3-8 times amount is added after crossing 80 mesh sieves, adopt ultrasonic extraction 1-3 time, extraction conditions comprises: ultrasonic power is 140-150W, Extracting temperature is 35-40 DEG C, and extraction time is 30-50min; Ultrasonic extraction is complete, gets filtrate, concentrating under reduced pressure drying obtains extract A;
(2) get Radix Triplostegiae Grandiflorae, Semen Cuscutae, Fructus Evodiae, Semen Astragali Complanati, Radix caricis siderostictae, Radix seu Caulis Embeliae Parviflorae, Arillus Longan pulverizing, add 5-10 times of water soaking 3-4 hour, decoct extraction twice, timing from during boiling, each 1.5-2.0 hour; Merge extractive liquid, filter, record relative density 1.05-1.10 when being concentrated into 60 DEG C, add ethanol and make alcohol content be 30-35%, leave standstill after 24 hours, centrifugal 20 minutes, (rotating speed is 3000r/min), discards lower sediment thing, obtains supernatant, after being concentrated into relative density 1.05-1.10 (60 DEG C record), spraying dry obtains extract B;
(3) by extract A extract B mix homogeneously, this composition is independent or mix with medicine acceptable carrier, makes pharmaceutical preparation of the present invention according to galenic pharmacy routine techniques.
The present invention be inventor through repeatedly studying, progressively improve, the good pharmaceutical preparation of last successful a kind of curative effect, and demonstrated the curative effect of pharmaceutical preparation of the present invention by clinical case further, particulars is as described below:
1 data and method
1.1 physical data: observe in JIUYUE, 2013 to 2014 and to go to a doctor year August in my institute's Out-patient Clinic of Department of Gynecology and be diagnosed as patient 128 example that Hypomenorrhea card belongs to cold blood stasis card, be divided into observation group and matched group to observe at random, often organize 64 routine.Observation group age 18-40 year, 25.2 ± 3.8 years old mean age, matched group age 18-39 year, average 24.9 ± 3.6 years old; Observation group's course of disease is the longest 6.5 years, the shortest 6 months, and average 2.25 ± 1.18 years, the matched group course of disease was the longest 6.5 years, the shortest 7 months, average 2.06 ± 1.01 years; 14 examples that observation group's state of an illness is slight, moderate 29 example, severe 21 example; 12 examples that the matched group state of an illness is slight, moderate 30 example, severe 22 example, two groups of physical data compare no difference of science of statistics (P > 0.05), have comparability.
1.2 diagnostic criterias: the diagnostic criteria of writing the hypomenorrhea of " guideline of clinical investigations of new Chinese medicine treatment menoxenia " of " Gynecology of Chinese Medicine " and Ministry of Health of the People's Republic of China promulgation in 2002 according to Zhang Yuzhen etc.
Hypomenorrhea: hypomenorrhea refers to that menstrual cycle is normal, and menstrual blood loss comparatively constant obviously reduces, and even drop is namely clean, or through line time less than 2 days, through the menopathy that amount is also few.
Standards of Chinese Medical Syndrome Differentiation: with reference to the related content of " guideline of clinical investigations of new Chinese medicine treatment menoxenia " that Ministry of Health of the People's Republic of China promulgates for 2002, formulate cold blood stasis card CM syndrome differentiation criterion: premenstrual or menstrual period lack abdomen cold type of pain, the warm tenderness of happiness, Hypomenorrhea, dark menses clot, aversion to cold and cold limbs, and leucorrhea amount is many, lumbosacral aching pain, deep and tense pulse, thin white fur of tongue or greasy in vain.
1.3 exclusion standards: have cryptorrhea, luteal phase defect, uterine cavity organic disease person; There are the Chronic consumptions persons such as hyperthyroidism, tuberculosis, severe anemia; There is oral hormone in 3 months, use contraceptive person; Untoward reaction person is there is in drug administration process; Not by regulation medication, cannot judge that curative effect or data are not congruent and affect the treatment or statistical disposition person.
1.4 Therapeutic Method:
Observation group: the capsule that menstruation brings into use the embodiment of the present invention 1 to prepare on the 5th day, 2-4 grain, took and withdrew to during menstrual onset every day, is a course for the treatment of, takes 3 months continuously with 3 months.
Matched group: use Western medicine capable artificial cycle estrogen and progestogen sequential therapy, from menstruation the 5th day, the oral progynova 1mg of patient, 1 time/d, serve on 21d; Started from the 15th day, add with Progesterone soft gelatin capsule 100mg, 2 times/d, take to the 21st day and progynova drug withdrawal simultaneously.Continuous treatment 3 menstrual cycle.
1.5 treatment fore-and-aft observing indexs:
1.5.1 change--menstrual blood volume color, the matter for the treatment of front and back menstruation, pass through the time, menstrual cycle.
1.5.2 symptom score before and after treatment.Standard: slight: less than 8 points, moderate: 8.5 ~ 12.5 points; Severe: more than 13 points.Cardinal symptom standards of grading: spanomenorrhea 1/3 or less than 2d, whole menstrual cycle 7 ~ 10 pieces of paper washers 5 points; Reduce 1/2, share paper washer 3 ~ 6 pieces 6 points; Menstruation drop is namely clean, with paper washer 1 ~ 2 piece 7 points.With lower abdomen or few abdomen cold type of pain 2 points, the warm tenderness 2 points of happiness, aversion to cold and cold limbs 1 point, lumbosacral aching pain 1 point, has clot 1 point, deep and tense pulse 0.5 point, profuse leukorrhea 0.5 point.
1.5.3 the observation of adverse effect during medication: with or without occurring untoward reaction and record during observing medication, as gastrointestinal upset, anaphylaxis, vaginal bleeding time prolongation etc.As the person that occurs serious adverse reaction, discontinue medication immediately, exit this research.
1.5.4 following up a case by regular visits to property observation: treatment is followed up a case by regular visits to after terminating rear third time menstrual onset, record related symptoms is observed.
1.7 statistical methods: adopt SPSS16.0 statistical software to calculate.Each numerical value with
represent, measurement data adopts t inspection, and enumeration data adopts χ
2inspection, with P < 0.05 for difference has statistical significance.
2 results
2.1 criterions of therapeutical effect: according to " guideline of clinical investigations of new Chinese medicine treatment menoxenia ", draft following criterion of therapeutical effect: recovery from illness: treat rear menstrual cycle, recover normal through amount, other transference cures, drug withdrawal 3 non-recidivists of menstrual cycle.Effective: menstrual blood volume increases by 1/3, and other transference cures alleviate, integration reduces 70% before comparatively treating, and drug withdrawal 3 menstrual cycle are without recidivist.Effective: treat rear menstrual cycle, through amount, comparatively treat front improvement menstrual period, other symptoms alleviate before comparatively treating, integration reduces 30 ~ 69% before comparatively controlling.Invalid: treatment after menstrual cycle, through amount and menstrual period without improvement, integration comparatively treat before reduce less than 30%.
2.2 observation of curative effect
2.2.1 two groups of patient's comparitive study: after above-mentioned 128 routine patient treatments, observation group cures 22 examples, effective 27 examples, and take a turn for the better 14 examples, invalid 1 example, obvious effective rate 76.6%, total effective rate 98.4%; Matched group cures 12 examples, effective 18 examples, take a turn for the better 21 examples, invalid 13 examples, obvious effective rate 46.9%, total effective rate 78.1%, observation group compares with matched group obvious effective rate, total effective rate, difference has statistical significance (P < 0.05), illustrates that clinical cure rate and the obvious effective rate of hypomenorrhea significantly can improve compared with matched group in observation group.In table 1.
Table 1 liang group patient comparitive study (n%, example)
Note: compare with matched group, * P < 0.05.
2.2.2 two groups of symptom integral compare: treat between front two groups of clinical symptoms total mark groups and compare not statistically significant (P > 0.05), illustrate that two groups have homogeneity comparability before the treatment.After different Therapeutic Method, two groups of clinical symptoms total marks more all have remarkable statistical significance (P < 0.01) before the treatment with between group after treatment, illustrate that two kinds of Therapeutic Method all have obvious therapeutic effect for the clinical symptoms of hypomenorrhea patient; And treatment after between clinical symptoms total mark observation group and matched group group the poor opposite sex there is statistical significance (P < 0.05), observation group's more effective clinical symptoms improving patient compared with matched group is described.
When following up a case by regular visits to after treatment is finished, clinical symptoms total mark compares with clinical symptoms total mark after treatment, compare in observation group's group and have statistical significance (P < 0.05), illustrate that observation group patient compares clinical symptoms and is improved when following up a case by regular visits to after treatment.Compare not statistically significant (P > 0.05) in matched group group, illustrate that the patient of matched group clinical symptoms after drug withdrawal has bounce-back.Can illustrate that observation group compares with matched group and has better late result accordingly, and the clinical symptoms of patient not easily recurs, and also demonstrates pharmaceutical preparation of the present invention and can treat cold blood stasis type hypomenorrhea, makes body obtain good recovery.In table 2.
Table 2 is treated the two groups of symptom integral in front and back and is compared
Note: compare with before treatment, * P < 0.05, * * P < 0.01, compares with after treatment of control group,
#p < 0.05, compares with after treatment of control group when following up a case by regular visits to
△p < 0.05.
2.2.3 the observation of adverse effect during medication: have 1 routine patient to occur slight gastrointestinal reaction during observation group's patient medication.15 routine patients are had to occur slight gastrointestinal reaction during matched group patient medication, as Nausea and vomiting, upper abdomen dull pain; Have 3 routine patients to occur irregular colporrhagia, observation group compares with matched group, and difference has statistical significance, and observation group's less adverse effect, patient compliance is better.
Therapeutic outcome shows: observation group can significantly improve clinical cure rate and the obvious effective rate of hypomenorrhea compared with matched group; Significantly can improve the clinical symptoms of patient, have better late result, and the clinical symptoms of patient not easily recurs, untoward reaction is few, is one pharmaceutical preparation safely and effectively, for Chinese medicine hypomenorrhea provides new method.
In a word, compared with prior art, the present invention has following beneficial effect:
Selected by pharmaceutical preparation of the present invention, medical material compatibility is suitable, meets Chinese medicine and pharmacy and modern medicine theory, and comprehensively, medication is thoughtful, plays warming the spleen warming the kidney altogether in legislation, dispelling cold by warming the meridian, blood circulation promoting and blood stasis dispelling, the effect of nourishing blood for regulating menstruation, makes kidney essense foot, kidney yang is contained, and agitates strong, and blood Wen Tongnuan palace, wantonly two beniols of cold loose then punching; QI and blood is in harmonious proportion, then the sea of blood is completely full of abundance; Taste spleen invigorating sun rises, and be jammed to rush without cold-damp and appoint, then essence and blood is descending without hindrance, and menstruation comes at the appointed time.
The present invention, based on dialectical theory, catches patient's insufficiency of kidney-YANG originally, takes into account liver spleen, coordinating YIN and YANG, strengthening vital QI to eliminate pathogenic factors, side effect is less, and patient compliance is better, taking convenience, can effectively alleviate patient's burden and misery, the object for the treatment of both the principal and secondary aspects of a disease can be reached, and approved by extensive patients.
Detailed description of the invention
Further describe the present invention below by way of specific embodiment, the present invention is not limited only to following examples.Within the scope of the invention or not departing from content of the present invention, spirit and scope, the change carried out the present invention, combination or replacement, be apparent for a person skilled in the art, and be included within the scope of the present invention.
Embodiment 1
Prescription: Herba Cyperi Iriae 25 parts, Radix Triplostegiae Grandiflorae 30 parts, Semen Cuscutae 20 parts, Fructus Evodiae 8 parts, three select gold grass 15 parts, Semen Astragali Complanati 15 parts, Radix caricis siderostictae 12 parts, Litsea coreana 10 parts, 6 parts, Rhizoma Curcumae Longae, Radix seu Caulis Embeliae Parviflorae 23 parts, Herba Leonuri 12 parts, Arillus Longan 18 parts, Folium Rhododendri Simsii 12 parts.
Preparation method:
(1) Herba Cyperi Iriae, 3 gold grass, Litsea coreana, Rhizoma Curcumae Longae, Herba Leonuri, Folium Rhododendri Simsiis are pulverized, the ethanol water of 50% of 3-8 times amount is added after crossing 80 mesh sieves, adopt ultrasonic extraction 1-3 time, extraction conditions comprises: ultrasonic power is 140-150W, Extracting temperature is 35-40 DEG C, and extraction time is 30-50min; Ultrasonic extraction is complete, gets filtrate, concentrating under reduced pressure drying obtains extract A;
(2) get Radix Triplostegiae Grandiflorae, Semen Cuscutae, Fructus Evodiae, Semen Astragali Complanati, Radix caricis siderostictae, Radix seu Caulis Embeliae Parviflorae, Arillus Longan pulverizing, add 5-10 times of water soaking 3-4 hour, decoct extraction twice, timing from during boiling, each 1.5-2.0 hour; Merge extractive liquid, filter, record relative density 1.05-1.10 when being concentrated into 60 DEG C, add ethanol and make alcohol content be 30-35%, leave standstill after 24 hours, centrifugal 20 minutes, (rotating speed is 3000r/min), discards lower sediment thing, obtains supernatant, after being concentrated into relative density 1.05-1.10 (60 DEG C record), spraying dry obtains extract B;
(3) by extract A extract B mix homogeneously, capsule is made according to galenic pharmacy routine techniques.
The capsule that the present embodiment is obtained, every 0.34g, containing crude drug 2.06g.
Embodiment 2
Prescription: Herba Cyperi Iriae 24 parts, Radix Triplostegiae Grandiflorae 28 parts, Semen Cuscutae 22 parts, Fructus Evodiae 5 parts, three select gold grass 13 parts, Semen Astragali Complanati 18 parts, Radix caricis siderostictae 10 parts, Litsea coreana 12 parts, 5 parts, Rhizoma Curcumae Longae, Radix seu Caulis Embeliae Parviflorae 20 parts, Herba Leonuri 10 parts, Arillus Longan 18 parts, Folium Rhododendri Simsii 10 parts.
Preparation method: with reference to embodiment 1.
Embodiment 3
Prescription: Herba Cyperi Iriae 20 parts, Radix Triplostegiae Grandiflorae 25 parts, Semen Cuscutae 15 parts, Fructus Evodiae 6 parts, three select gold grass 18 parts, Semen Astragali Complanati 18 parts, Radix caricis siderostictae 10 parts, Litsea coreana 12 parts, 4 parts, Rhizoma Curcumae Longae, Radix seu Caulis Embeliae Parviflorae 20 parts, Herba Leonuri 10 parts, Arillus Longan 15 parts, Folium Rhododendri Simsii 8 parts.
Preparation method: with reference to embodiment 1.
Embodiment 4
Prescription: Herba Cyperi Iriae 25 parts, Radix Triplostegiae Grandiflorae 25 parts, Semen Cuscutae 23 parts, Fructus Evodiae 6 parts, three select gold grass 16 parts, Semen Astragali Complanati 18 parts, Radix caricis siderostictae 15 parts, Litsea coreana 12 parts, 4 parts, Rhizoma Curcumae Longae, Radix seu Caulis Embeliae Parviflorae 20 parts, Herba Leonuri 10 parts, Arillus Longan 15 parts, Folium Rhododendri Simsii 15 parts.
Preparation method: with reference to embodiment 1.
Embodiment 5
Prescription: Herba Cyperi Iriae 28 parts, Radix Triplostegiae Grandiflorae 35 parts, Semen Cuscutae 23 parts, Fructus Evodiae 9 parts, three select gold grass 15 parts, Semen Astragali Complanati 20 parts, Radix caricis siderostictae 15 parts, Litsea coreana 10 parts, 7 parts, Rhizoma Curcumae Longae, Radix seu Caulis Embeliae Parviflorae 18 parts, Herba Leonuri 8 parts, Arillus Longan 15 parts, Folium Rhododendri Simsii 15 parts.
Preparation method: with reference to embodiment 1.
Embodiment 6
Prescription: Herba Cyperi Iriae 25 parts, Radix Triplostegiae Grandiflorae 36 parts, Semen Cuscutae 15 parts, Fructus Evodiae 6 parts, three select gold grass 15 parts, Semen Astragali Complanati 18 parts, Radix caricis siderostictae 10 parts, Litsea coreana 15 parts, 7 parts, Rhizoma Curcumae Longae, Radix seu Caulis Embeliae Parviflorae 18 parts, Herba Leonuri 13 parts, Arillus Longan 16 parts, Folium Rhododendri Simsii 6 parts.
Preparation method: with reference to embodiment 1.
Embodiment 7
Prescription: Herba Cyperi Iriae 30 parts, Radix Triplostegiae Grandiflorae 40 parts, Semen Cuscutae 18 parts, Fructus Evodiae 5 parts, three select gold grass 13 parts, Semen Astragali Complanati 15 parts, Radix caricis siderostictae 15 parts, Litsea coreana 12 parts, 6 parts, Rhizoma Curcumae Longae, Radix seu Caulis Embeliae Parviflorae 25 parts, Herba Leonuri 12 parts, Arillus Longan 15 parts, Folium Rhododendri Simsii 10 parts.
Preparation method: with reference to embodiment 1.
Embodiment 8
Prescription: Herba Cyperi Iriae 24 parts, Radix Triplostegiae Grandiflorae 32 parts, Semen Cuscutae 15 parts, Fructus Evodiae 9 parts, three select gold grass 13 parts, Semen Astragali Complanati 18 parts, Radix caricis siderostictae 15 parts, Litsea coreana 15 parts, 5 parts, Rhizoma Curcumae Longae, Radix seu Caulis Embeliae Parviflorae 25 parts, Herba Leonuri 13 parts, Arillus Longan 18 parts, Folium Rhododendri Simsii 10 parts.
Preparation method: with reference to embodiment 1.
Embodiment 9
Prescription: Herba Cyperi Iriae 25 parts, Radix Triplostegiae Grandiflorae 30 parts, Semen Cuscutae 20 parts, Fructus Evodiae 8 parts, three select gold grass 15 parts, Semen Astragali Complanati 15 parts, Radix caricis siderostictae 12 parts, Litsea coreana 10 parts, 6 parts, Rhizoma Curcumae Longae, Radix seu Caulis Embeliae Parviflorae 23 parts, Herba Leonuri 12 parts, Arillus Longan 18 parts, Folium Rhododendri Simsii 12 parts.
Preparation method:
(1) Herba Cyperi Iriae, 3 gold grass, Litsea coreana, Rhizoma Curcumae Longae, Herba Leonuri, Folium Rhododendri Simsiis are pulverized, the ethanol water of 50% of 3-8 times amount is added after crossing 80 mesh sieves, adopt ultrasonic extraction 1-3 time, extraction conditions comprises: ultrasonic power is 140-150W, Extracting temperature is 35-40 DEG C, and extraction time is 30-50min; Ultrasonic extraction is complete, gets filtrate, concentrating under reduced pressure drying obtains extract A;
(2) get Radix Triplostegiae Grandiflorae, Semen Cuscutae, Fructus Evodiae, Semen Astragali Complanati, Radix caricis siderostictae, Radix seu Caulis Embeliae Parviflorae, Arillus Longan pulverizing, add 5-10 times of water soaking 3-4 hour, decoct extraction twice, timing from during boiling, each 1.5-2.0 hour; Merge extractive liquid, filter, record relative density 1.05-1.10 when being concentrated into 60 DEG C, add ethanol and make alcohol content be 30-35%, leave standstill after 24 hours, centrifugal 20 minutes, (rotating speed is 3000r/min), discards lower sediment thing, obtains supernatant, after being concentrated into relative density 1.05-1.10 (60 DEG C record), spraying dry obtains extract B;
(3) by extract A extract B mix homogeneously, tablet is made according to galenic pharmacy routine techniques.
Embodiment 10
Prescription: Herba Cyperi Iriae 25 parts, Radix Triplostegiae Grandiflorae 30 parts, Semen Cuscutae 20 parts, Fructus Evodiae 8 parts, three select gold grass 15 parts, Semen Astragali Complanati 15 parts, Radix caricis siderostictae 12 parts, Litsea coreana 10 parts, 6 parts, Rhizoma Curcumae Longae, Radix seu Caulis Embeliae Parviflorae 23 parts, Herba Leonuri 12 parts, Arillus Longan 18 parts, Folium Rhododendri Simsii 12 parts.
Preparation method:
(1) Herba Cyperi Iriae, 3 gold grass, Litsea coreana, Rhizoma Curcumae Longae, Herba Leonuri, Folium Rhododendri Simsiis are pulverized, the ethanol water of 50% of 3-8 times amount is added after crossing 80 mesh sieves, adopt ultrasonic extraction 1-3 time, extraction conditions comprises: ultrasonic power is 140-150W, Extracting temperature is 35-40 DEG C, and extraction time is 30-50min; Ultrasonic extraction is complete, gets filtrate, concentrating under reduced pressure drying obtains extract A;
(2) get Radix Triplostegiae Grandiflorae, Semen Cuscutae, Fructus Evodiae, Semen Astragali Complanati, Radix caricis siderostictae, Radix seu Caulis Embeliae Parviflorae, Arillus Longan pulverizing, add 5-10 times of water soaking 3-4 hour, decoct extraction twice, timing from during boiling, each 1.5-2.0 hour; Merge extractive liquid, filter, record relative density 1.05-1.10 when being concentrated into 60 DEG C, add ethanol and make alcohol content be 30-35%, leave standstill after 24 hours, centrifugal 20 minutes, (rotating speed is 3000r/min), discards lower sediment thing, obtains supernatant, after being concentrated into relative density 1.05-1.10 (60 DEG C record), spraying dry obtains extract B;
(3) by extract A extract B mix homogeneously, granule is made according to galenic pharmacy routine techniques.
Claims (10)
1. treat a pharmaceutical preparation for cold blood stasis type Hypomenorrhea, it is characterized in that selecting gold grass by Herba Cyperi Iriae, Radix Triplostegiae Grandiflorae, Semen Cuscutae, Fructus Evodiae, three, Semen Astragali Complanati, Radix caricis siderostictae, Litsea coreana, Rhizoma Curcumae Longae, Radix seu Caulis Embeliae Parviflorae, Herba Leonuri, Arillus Longan, Folium Rhododendri Simsii be that medicinal raw material is made.
2. pharmaceutical preparation as claimed in claim 1, is characterized in that being made up of the medicinal raw material of following weight portion: Herba Cyperi Iriae 20-30 part, Radix Triplostegiae Grandiflorae 20-40 part, Semen Cuscutae 15-25 part, Fructus Evodiae 5-9 part, three select the careless 13-18 part of gold, Semen Astragali Complanati 15-20 part, Radix caricis siderostictae 10-15 part, Litsea coreana 10-15 part, Rhizoma Curcumae Longae 4-7 part, Radix seu Caulis Embeliae Parviflorae 18-26 part, Herba Leonuri 8-13 part, Arillus Longan 15-20 part, Folium Rhododendri Simsii 5-15 part.
3. pharmaceutical preparation as claimed in claim 2, is characterized in that being made up of the medicinal raw material of following weight portion: Herba Cyperi Iriae 24-28 part, Radix Triplostegiae Grandiflorae 28-32 part, Semen Cuscutae 18-23 part, Fructus Evodiae 5-9 part, three select the careless 13-18 part of gold, Semen Astragali Complanati 15-20 part, Radix caricis siderostictae 10-15 part, Litsea coreana 10-15 part, Rhizoma Curcumae Longae 4-7 part, Radix seu Caulis Embeliae Parviflorae 20-25 part, Herba Leonuri 8-13 part, Arillus Longan 15-20 part, Folium Rhododendri Simsii 10-15 part.
4. pharmaceutical preparation as claimed in claim 3, is characterized in that being made up of the medicinal raw material of following preferred weight part: Herba Cyperi Iriae 25 parts, Radix Triplostegiae Grandiflorae 30 parts, Semen Cuscutae 20 parts, Fructus Evodiae 8 parts, three select gold grass 15 parts, Semen Astragali Complanati 15 parts, Radix caricis siderostictae 12 parts, Litsea coreana 10 parts, 6 parts, Rhizoma Curcumae Longae, Radix seu Caulis Embeliae Parviflorae 23 parts, Herba Leonuri 12 parts, Arillus Longan 18 parts, Folium Rhododendri Simsii 12 parts.
5. the pharmaceutical preparation as described in claim 1-4, is characterized in that preparation method mainly comprises the following steps:
(1) Herba Cyperi Iriae, 3 gold grass, Litsea coreana, Rhizoma Curcumae Longae, Herba Leonuri, Folium Rhododendri Simsiis are pulverized, the ethanol water of 50% of 3-8 times amount is added after crossing 80 mesh sieves, adopt ultrasonic extraction 1-3 time, extraction conditions comprises: ultrasonic power is 140-150W, Extracting temperature is 35-40 DEG C, and extraction time is 30-50min; Ultrasonic extraction is complete, gets filtrate, concentrating under reduced pressure drying obtains extract A;
(2) get Radix Triplostegiae Grandiflorae, Semen Cuscutae, Fructus Evodiae, Semen Astragali Complanati, Radix caricis siderostictae, Radix seu Caulis Embeliae Parviflorae, Arillus Longan pulverizing, add 5-10 times of water soaking 3-4 hour, decoct extraction twice, timing from during boiling, each 1.5-2.0 hour; Merge extractive liquid, filter, record relative density 1.05-1.10 when being concentrated into 60 DEG C, add ethanol and make alcohol content be 30-35%, leave standstill after 24 hours, centrifugal 20 minutes, (rotating speed is 3000r/min), discards lower sediment thing, obtains supernatant, after being concentrated into relative density 1.05-1.10 (60 DEG C record), spraying dry obtains extract B;
(3) by extract A extract B mix homogeneously, this composition is independent or mix with medicine acceptable carrier, makes pharmaceutical preparation of the present invention according to galenic pharmacy routine techniques.
6. the pharmaceutical preparation as described in claim 1-5, is characterized in that described pharmaceutical preparation is peroral dosage form.
7. pharmaceutical preparation as claimed in claim 6, is characterized in that described peroral dosage form is tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, sucks agent, granule, electuary, honey pill agent, powder, sublimed preparation, solution or plaster etc.
8. pharmaceutical preparation as claimed in claim 7, is characterized in that described peroral dosage form is preferably tablet, capsule or granule.
9. pharmaceutical preparation as claimed in claim 8, is characterized in that described peroral dosage form is preferably capsule.
10. the application of the arbitrary described pharmaceutical preparation of claim 1-9 in the medicine of preparation treatment cold blood stasis type Hypomenorrhea.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20110112231A (en) * | 2010-04-06 | 2011-10-12 | (주)아모레퍼시픽 | Fermentation method using medicinal leaf and skin external composition containing fermented extract by the method |
| CN104189349A (en) * | 2014-09-24 | 2014-12-10 | 王深涧 | Traditional Chinese medicine composition for treating oligomenorrhea |
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- 2015-12-21 CN CN201510968325.3A patent/CN105362963A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20110112231A (en) * | 2010-04-06 | 2011-10-12 | (주)아모레퍼시픽 | Fermentation method using medicinal leaf and skin external composition containing fermented extract by the method |
| CN104189349A (en) * | 2014-09-24 | 2014-12-10 | 王深涧 | Traditional Chinese medicine composition for treating oligomenorrhea |
Non-Patent Citations (1)
| Title |
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| 段玮玮等: "右归丸加减治疗月经过少56例", 《陕西中医》 * |
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